[Federal Register Volume 70, Number 230 (Thursday, December 1, 2005)]
[Notices]
[Pages 72128-72132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-6718]
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NUCLEAR REGULATORY COMMISSION
[Docket Nos: (Redacted), License Nos: (Redacted), EA-05-090]
In the Matter of All Licensees Authorized To Possess Radioactive
Material Quantities of Concern, Order Imposing Increased Controls
(Effective Immediately)
I
The Licensees identified in Attachment A \1\ to this Order hold
licenses issued in accordance with the Atomic Energy Act of 1954 by the
U.S. Nuclear Regulatory Commission (NRC or Commission) authorizing them
to possess certain quantities of radioactive material of concern.
Commission regulations at 10 CFR 20.1801 require Licensees to secure,
from unauthorized removal or access, licensed materials that are stored
in controlled or unrestricted areas. Commission regulations at 10 CFR
20.1802 require Licensees to control and maintain constant surveillance
of licensed material that is in a controlled or unrestricted area and
that is not in storage.
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\1\ Attachment A contains sensitive information and will not be
released to the public.
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II
Prior to the terrorist attacks of September 11, 2001 (9/11),
several national and international efforts were underway to address the
potentially significant health and safety hazards posed by uncontrolled
sources. These efforts recognized the need for increased control of
high-risk radioactive materials to prevent inadvertent and intentional
unauthorized access, primarily due to the potential health and safety
hazards posed by the uncontrolled material. Following 9/11, it was
recognized that these efforts should also include a heightened
awareness and focus on the need to prevent intentional unauthorized
access due to potential malicious acts. These efforts, such as the
International Atomic Energy Agency (IAEA) Code of Conduct
[[Page 72129]]
on the Safety and Security of Radioactive Sources (Code of Conduct)
concerning Category 1 and 2 sources, seek to increase the control over
sources to prevent unintended radiation exposure and to prevent
malicious acts.
A Licensee's loss of control of high-risk radioactive sources,
whether it be inadvertent or through a deliberate act, has a potential
to result in significant adverse health impacts and could reasonably
constitute a threat to the public health and safety. In this regard,
the Commission has determined that certain additional controls are
required to be implemented by Licensees to supplement existing
regulatory requirements in 10 CFR 20.1801 and 10 CFR 20.1802, in order
to ensure adequate protection of, and minimize danger to, the public
health and safety. Therefore, the Commission is imposing the
requirements set forth in Attachment B on radioactive materials
Licensees who possess, or have near term plans to possess,
radionuclides of concern at or above threshold limits, identified in
Table 1. These requirements, which supplement existing regulatory
requirements, will provide the Commission with reasonable assurance
that the public health and safety continues to be adequately protected.
These requirements will remain in effect until the Commission modifies
its regulations to reflect increased controls.
To effect nationwide implementation, these measures have been
determined by the Commission to be an immediate mandatory Category
``B'' matter of compatibility for Agreement States. In parallel with
the Commission's issuance of this Order, each Agreement State is
required to issue legally binding requirements to put essentially
identical measures in place for Licensees under their regulatory
jurisdiction.
The Commission recognizes that Licensees may have already initiated
many controls set forth in Attachment B to this Order in response to
previously issued advisories or on their own. It is also recognized
that some controls may not be possible or necessary at some sites, or
may need to be tailored to accommodate the Licensees' specific
circumstances to achieve the intended objectives and avoid any
unforeseen adverse effect on the safe use and storage of the sealed
sources.
Although the additional controls implemented by the Licensees in
response to the Safeguards and Threat Advisories have been adequate to
provide reasonable assurance of adequate protection of public health
and safety, the Commission concludes that additional controls must be
imposed by an Order, consistent with the established regulatory
framework.
To provide assurance that the Licensees are implementing prudent
measures to achieve a consistent level of control, all Licensees who
hold licenses issued by the NRC authorizing possession of radioactive
material quantities of concern and as listed in Table 1,
``Radionuclides of Concern,'' (Attachment B, Table 1), shall implement
the requirements identified in Attachment B to this Order. In addition,
pursuant to 10 CFR 2.202, because of the potentially significant
adverse health impacts associated with failure to control high risk
radioactive sources, I find that the public health, safety, and
interest require that this Order be effective immediately.
III
Accordingly, pursuant to Sections 81, 161b, 161i, 161o, 182 and 186
of the Atomic Energy Act of 1954, as amended, and the Commission's
regulations in 10 CFR 2.202, 10 CFR part 30, and 10 CFR part 33, it is
hereby ordered, effective immediately, that all Licensees identified in
attachment A to this order shall comply with the requirements of this
order as follows:
A. The Licensee shall comply with the requirements described in
Attachment B to this Order. The Licensee shall complete implementation
by May 13, 2006, or the first day that radionuclides of concern at or
above threshold limits, identified in Table 1, are possessed, whichever
occurs later.
B.1. The Licensee shall in writing, within twenty five (25) days of
the date of this Order, notify the Commission, (1) If it is unable to
comply with any of the requirements described in Attachment B, (2) if
compliance with any of the requirements is unnecessary in its specific
circumstances, or (3) if implementation of any of the requirements
would cause the Licensee to be in violation of the provisions of any
Commission regulation or its license. The notification shall provide
the Licensee's justification for seeking relief from or variation of
any specific requirement.
B.2. If the Licensee considers that implementation of any of the
requirements described in Attachment B to this Order would adversely
impact safe operation of the facility, the Licensee must notify the
Commission, in writing, within twenty five (25) days of this Order, of
the adverse safety impact, the basis for its determination that the
requirement has an adverse safety impact, and either a proposal for
achieving the same objectives specified in the Attachment B requirement
in question, or a schedule for modifying the facility to address the
adverse safety condition. If neither approach is appropriate, the
Licensee must supplement its response to Condition B.1 of this Order to
identify the condition as a requirement with which it cannot comply,
with attendant justifications as required in Condition B.1.
C.1. The Licensee shall, within twenty five (25) days of the date
of this Order, submit to the Commission a schedule for completion of
each requirement described in Attachment B.
C.2. The Licensee shall report to the Commission when they have
achieved full compliance with the requirements described in Attachment
B.
D. Notwithstanding any provisions of the Commission's regulations
to the contrary, all measures implemented or actions taken in response
to this Order shall be maintained until the Commission modifies its
regulations to reflect increased controls.
Licensee responses to Conditions B.1, B.2, C.1, and C.2 above shall
be submitted to the Director, Office of Nuclear Material Safety and
Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
In addition, Licensee's responses shall be marked as ``Withhold From
Public Disclosure Under 10 CFR 2.390.''
The Director, Office of Nuclear Material Safety and Safeguards,
may, in writing, relax or rescind any of the above conditions upon
demonstration by the Licensee of good cause.
IV
In accordance with 10 CFR 2.202, the Licensee must, and any other
person adversely affected by this Order may, submit an answer to this
Order, and may request a hearing on this Order, within twenty five (25)
days of the date of this Order. Where good cause is shown,
consideration will be given to extending the time to request a hearing.
A request for extension of time in which to submit an answer or request
a hearing must be made in writing to the Director, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555, and include a statement of good cause for the
extension. The answer may consent to this Order. Unless the answer
consents to this Order, the answer shall, in writing and under oath or
affirmation, specifically set forth the matters of fact and law on
which the Licensee or other person adversely affected relies and the
reasons as to why the Order should not have been issued. Any answer or
request for a hearing shall be submitted to the Secretary,
[[Page 72130]]
Office of the Secretary of the Commission, U.S. Nuclear Regulatory
Commission, ATTN: Rulemakings and Adjudications Staff, Washington, DC
20555. Copies also shall be sent to the Director, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555, to the Assistant General Counsel for Materials
Litigation and Enforcement at the same address, and to the Licensee if
the answer or hearing request is by a person other than the Licensee.
Because of possible disruptions in delivery of mail to United States
Government offices, it is requested that answers and requests for
hearing be transmitted to the Secretary of the Commission either by
means of facsimile transmission to 301-415-1101 or by e-mail to
[email protected] and also to the Office of the General Counsel
either by means of facsimile transmission to 301-415-3725 or by e-mail
to [email protected]. If a person other than the Licensee requests
a hearing, that person shall set forth with particularity the manner in
which his interest is adversely affected by this Order and shall
address the criteria set forth in 10 CFR 2.309(d) and (f).
If a hearing is requested by the Licensee or a person whose
interest is adversely affected, the Commission will issue an Order
designating the time and place of any hearing. If a hearing is held,
the issue to be considered at such hearing shall be whether this Order
should be sustained.
Pursuant to 10 CFR 2.202(c)(2)(I), the Licensee may, in addition to
demanding a hearing, at the time the answer is filed or sooner, move
the presiding officer to set aside the immediate effectiveness of the
Order on the ground that the Order, including the need for immediate
effectiveness, is not based on adequate evidence but on mere suspicion,
unfounded allegations, or error.
In the absence of any request for hearing, or written approval of
an extension of time in which to request a hearing, the provisions
specified in Section III above shall be final twenty five (25) days
from the date of this Order without further order or proceedings. If an
extension of time for requesting a hearing has been approved, the
provisions specified in Section III shall be final when the extension
expires if a hearing request has not been received. An answer or a
request for hearing shall not stay the immediate effectiveness of this
order.
Dated this 14th day of November 2005.
For the Nuclear Regulatory Commission.
Jack R. Strosnider, Jr.,
Director, Office of Nuclear Material Safety and Safeguards.
Attachment A--Redacted
Attachment B--Increased Controls for Licensees That Possess Sources
Containing Radioactive Material Quantities of Concern
The purpose of the increased controls (IC) for radioactive sources
is to enhance control of radioactive material in quantities greater
than or equal to values described in Table 1, to reduce the risk of
unauthorized use of radioactive materials, through access controls to
aid prevention, and prompt detection, assessment, and response to
mitigate potentially high consequences that would be detrimental to
public health and safety. These increased controls for radioactive
sources are established to delineate licensee responsibility to
maintain control of licensed material and secure it from unauthorized
removal or access. The following increased controls apply to licensees
which, at any given time, possess radioactive sources greater than or
equal to the quantities of concern of radioactive material defined in
Table 1.
IC1. In order to ensure the safe handling, use, and control of
licensed material in use and in storage each licensee shall control
access at all times to radioactive material quantities of concern and
devices containing such radioactive material (devices), and limit
access to such radioactive material and devices to only approved
individuals who require access to perform their duties.
a. The licensee shall allow only trustworthy and reliable
individuals, approved in writing by the licensee, to have unescorted
access to radioactive material quantities of concern and devices. The
licensee shall approve for unescorted access only those individuals
with job duties that require access to such radioactive material and
devices. Personnel who require access to such radioactive material and
devices to perform a job duty, but who are not approved by the licensee
for unescorted access, must be escorted by an approved individual.
b. For individuals employed by the licensee for 3 years or less,
and for non-licensee personnel, such as physicians, physicists, house-
keeping personnel, and security personnel under contract,
trustworthiness and reliability shall be determined, at a minimum, by
verifying employment history, education, and personal references. The
licensee shall also, to the extent possible, obtain independent
information to corroborate that provided by the employee (i.e., seeking
references not supplied by the individual). For individuals employed by
the licensee for longer than 3 years, trustworthiness and reliability
shall be determined, at a minimum, by a review of the employees'
employment history with the licensee.
c. Service providers shall be escorted unless determined to be
trustworthy and reliable by an NRC-required background investigation as
an employee of a manufacturing and distribution (M&D) licensee. Written
verification attesting to or certifying the person's trustworthiness
and reliability shall be obtained from the manufacturing and
distribution licensee providing the service.
d. The licensee shall document the basis for concluding that there
is reasonable assurance that an individual granted unescorted access is
trustworthy and reliable, and does not constitute an unreasonable risk
for unauthorized use of radioactive material quantities of concern. The
licensee shall maintain a list of persons approved for unescorted
access to such radioactive material and devices by the licensee.
IC2. In order to ensure the safe handling, use, and control of
licensed material in use and in storage, each licensee shall have a
documented program to monitor and immediately detect, assess, and
respond to unauthorized access to radioactive material quantities of
concern and devices. Enhanced monitoring shall be provided during
periods of source delivery or shipment, where the delivery or shipment
exceeds 100 times the Table 1 values.
a. The licensee shall respond immediately to any actual or
attempted theft, sabotage, or diversion of such radioactive material or
of the devices. The response shall include requesting assistance from a
Local Law Enforcement Agency (LLEA).
b. The licensee shall have a pre-arranged plan with LLEA for
assistance in response to an actual or attempted theft, sabotage, or
diversion of such radioactive material or of the devices which is
consistent in scope and timing with a realistic potential vulnerability
of the sources containing such radioactive material. The pre-arranged
plan shall be updated when changes to the facility design or operation
affect the potential vulnerability of the sources. Pre-arranged LLEA
coordination is not required for temporary job sites.
c. The licensee shall have a dependable means to transmit
information between, and among, the various components used to detect
and
[[Page 72131]]
identify an unauthorized intrusion, to inform the assessor, and to
summon the appropriate responder.
d. After initiating appropriate response to any actual or attempted
theft, sabotage, or diversion of radioactive material or of the
devices, the licensee shall, as promptly as possible, notify NRC
Operations Center at (301) 816-5100.
e. The licensee shall maintain documentation describing each
instance of unauthorized access and any necessary corrective actions to
prevent future instances of unauthorized access.
IC3.a. In order to ensure the safe handling, use, and control of
licensed material in transportation for domestic highway and rail
shipments by a carrier other than the licensee, for quantities that
equal or exceed those in Table 1 but are less than 100 times Table 1
quantities, per consignment, the licensee shall:
1. Use carriers which:
A. Use package tracking systems,
B. Implement methods to assure trustworthiness and reliability of
drivers,
C. Maintain constant control and/or surveillance during transit,
and
D. Have the capability for immediate communication to summon
appropriate response or assistance.
The licensee shall verify and document that the carrier employs the
measures listed above.
2. Contact the recipient to coordinate the expected arrival time of
the shipment;
3. Confirm receipt of the shipment; and
4. Initiate an investigation to determine the location of the
licensed material if the shipment does not arrive on or about the
expected arrival time. When, through the course of the investigation,
it is determined the shipment has become lost, stolen, or missing, the
licensee shall immediately notify the NRC Operations Center at (301)
816-5100. If, after 24 hours of investigating, the location of the
material still cannot be determined, the radioactive material shall be
deemed missing and the licensee shall immediately notify the NRC
Operations Center at (301) 816-5100.
b. For domestic highway and rail shipments, prior to shipping
licensed radioactive material that exceeds 100 times the quantities in
Table 1 per consignment, the licensee shall:
1. Notify the NRC,\1\ in writing, at least 90 days prior to the
anticipated date of shipment. The NRC will issue the Order to implement
the Additional Security Measures (ASMs) for the transportation of
Radioactive Material Quantities of Concern (RAM QC). The licensee shall
not ship this material until the ASMs for the transportation of RAM QC
are implemented or the licensee is notified otherwise, in writing, by
NRC.
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\1\ Director, Office of Nuclear Material Safety and Safeguards,
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
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2. Once the licensee has implemented the ASMs for the
transportation of RAM QC, the notification requirements of 3.b.1 shall
not apply to future shipments of licensed radioactive material that
exceeds 100 times the Table 1 quantities. The licensee shall implement
the ASMs for the transportation of RAM QC.
c. If a licensee employs an M&D licensee to take possession at the
licensee's location of the licensed radioactive material and ship it
under its M&D license, the requirements of 3.a. and 3.b above shall not
apply.
d. If the licensee is to receive radioactive material greater than
or equal to the Table 1 quantities, per consignment, the licensee shall
coordinate with the originator to:
1. Establish an expected time of delivery; and
2. Confirm receipt of transferred radioactive material. If the
material is not received at the expected time of delivery, notify the
originator and assist in any investigation.
IC4. In order to ensure the safe handling, use, and control of
licensed material in use and in storage each licensee that possesses
mobile or portable devices containing radioactive material in
quantities greater than or equal to Table 1 values, shall:
a. For portable devices, have two independent physical controls
that form tangible barriers to secure the material from unauthorized
removal when the device is not under direct control and constant
surveillance by the licensee.
b. For mobile devices:
1. That are only moved outside of the facility (e.g., on a
trailer), have two independent physical controls that form tangible
barriers to secure the material from unauthorized removal when the
device is not under direct control and constant surveillance by the
licensee.
2. That are only moved inside a facility, have a physical control
that forms a tangible barrier to secure the material from unauthorized
movement or removal when the device is not under direct control and
constant surveillance by the licensee.
c. For devices in or on a vehicle or trailer, licensees shall also
utilize a method to disable the vehicle or trailer when not under
direct control and constant surveillance by the licensee.
IC5. The licensee shall retain documentation required by these
increased controls for 3 years after they are no longer effective:
a. The licensee shall retain documentation regarding the
trustworthiness and reliability of individual employees for 3 years
after the individual's employment ends.
b. Each time the licensee revises the list of approved persons
required by 1.d., or the documented program required by 2, the licensee
shall retain the previous documentation for 3 years after the revision.
c. The licensee shall retain documentation on each radioactive
material carrier for 3 years after the licensee discontinues use of
that particular carrier.
d. The licensee shall retain documentation on shipment
coordination, notifications, and investigations for 3 years after the
shipment or investigation is completed.
e. After the license is terminated or amended to reduce possession
limits below the quantities of concern, the licensee shall retain all
documentation required by these increased controls for 3 years.
IC6. Detailed information generated by the licensee that describes
the physical protection of radioactive material quantities of concern,
is sensitive information and shall be protected from unauthorized
disclosure.
a. The licensee shall control access to its physical protection
information to those persons who have an established need to know the
information, and are considered to be trustworthy and reliable.
b. The licensee shall develop, maintain and implement policies and
procedures for controlling access to, and for proper handling and
protection against unauthorized disclosure of, its physical protection
information for radioactive material covered by these requirements. The
policies and procedures shall include the following:
1. General performance requirement that each person who produces,
receives, or acquires the licensee's sensitive information, protect the
information from unauthorized disclosure,
2. Protection of sensitive information during use, storage, and
transit,
3. Preparation, identification or marking, and transmission,
4. Access controls,
5. Destruction of documents,
6. Use of automatic data processing systems, and
7. Removal from the licensee's sensitive information category.
[[Page 72132]]
Table 1.--Radionuclides of Concern
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Quantity of Quantity of
Radionuclide concern concern
\1\ (TBq) \2\ (Ci)
------------------------------------------------------------------------
Am-241........................................ 0.6 16
Am-241/Be..................................... 0.6 16
Cf-252........................................ 0.2 5.4
Cm-244........................................ 0.5 14
Co-60......................................... 0.3 8.1
Cs-137........................................ 1 27
Gd-153........................................ 10 270
Ir-192........................................ 0.8 22
Pm-147........................................ 400 11,000
Pu-238........................................ 0.6 16
Pu-239/Be..................................... 0.6 16
Se-75......................................... 2 54
Sr-90 (Y-90).................................. 10 270
Tm-170........................................ 200 5,400
Yb-169........................................ 3 81
Combinations of radioactive materials listed (\4\) ...........
above \3\....................................
------------------------------------------------------------------------
\1\ The aggregate activity of multiple, collocated sources of the same
radionuclide should be included when the total activity equals or
exceeds the quantity of concern.
\2\ The primary values used for compliance with this Order are TBq. The
curie (Ci) values are rounded to two significant figures for
informational purposes only.
\3\ Radioactive materials are to be considered aggregated or collocated
if breaching a common physical security barrier (e.g., a locked door
at the entrance to a storage room) would allow access to the
radioactive material or devices containing the radioactive material.
\4\ If several radionuclides are aggregated, the sum of the ratios of
the activity of each source, I of radionuclide, n, A(i,n), to the
quantity of concern for radionuclide n, Q(n), listed for that
radionuclide equals or exceeds one. [(aggregated source activity for
radionuclide A) (quantity of concern for radionuclide A)] +
[(aggregated source activity for radionuclide B) (quantity of concern
for radionuclide B)] + etc. ...... >1.
Use the following method to determine which sources of radioactive
material require increased controls (ICs):
Include any single source equal to or greater than the quantity of
concern in Table 1.
Include multiple collocated sources of the same radionuclide when
the combined quantity equals or exceeds the quantity of concern.
For combinations of radionuclides, include multiple collocated
sources of different radionuclides when the aggregate quantities
satisfy the following unity rule: [(amount of radionuclide A) (quantity
of concern of radionuclide A)] + [(amount of radionuclide B) (quantity
of concern of radionuclide B)] + etc. ......>1.
Guidance for Aggregation of Sources
NRC supports the use of the IAEA's source categorization
methodology as defined in TECDOC-1344, ``Categorization of Radioactive
Sources,'' (July 2003) (see http://www-pub.iaea.org/MTCD/publications/PDF/te_1344_web.pdf) and as endorsed by the agency's Code of Conduct
for the Safety and Security of Radioactive Sources, January 2004 (see
http://www-pub.iaea.org/MTCD/publications/PDF/Code-2004_web.pdf). The
Code defines a three-tiered source categorization scheme. Category 1
corresponds to the largest source strength (equal to or greater than
100 times the quantity of concern values listed in Table 1.) and
Category 3, the smallest (equal or exceeding one-tenth the quantity of
concern values listed in Table 1.). Increased controls apply to sources
that are equal to or greater than the quantity of concern values listed
in Table 1, plus aggregations of smaller sources that are equal to or
greater than the quantities in Table 1. Aggregation only applies to
sources that are collocated.
Licensees who possess individual sources in total quantities that
equal or exceed the Table 1 quantities are required to implement
increased controls. Where there are many small (less than the quantity
of concern values) collocated sources whose total aggregate activity
equals or exceeds the Table 1 values, licensees are to implement
increased controls.
Some source handling or storage activities may cover several
buildings, or several locations within specific buildings. The question
then becomes: When are sources considered collocated for purposes of
aggregation? For purposes of the additional controls, sources are
considered collocated if breaching a single barrier (e.g., a locked
door at the entrance to a storage room) would allow access to the
sources. Sources behind an outer barrier should be aggregated
separately from those behind an inner barrier (e.g., a locked source
safe inside the locked storage room). However, if both barriers are
simultaneously open, then all sources within these two barriers are
considered to be collocated. This logic should be continued for other
barriers within or behind the inner barrier.
The following example illustrates the point: A lockable room has
sources stored in it. Inside the lockable room, there are two shielded
safes with additional sources in them. Inventories are as follows:
The room has the following sources outside the safes: Cf-252, 0.12
TBq (3.2 Ci); Co-60, 0.18 TBq (4.9 Ci), and Pu-238, 0.3 TBq (8.1 Ci).
Application of the unity rule yields: (0.12 0.2) + (0.18 0.3) + (0.3
0.6) = 0.6 + 0.6 + 0.5 = 1.7. Therefore, the sources would require
increased controls.
Shielded safe 1 has a 1.9 TBq (51 Ci) Cs-137 source and a
0.8 TBq (22 Ci) Am-241 source. In this case, the sources would require
increased controls, regardless of location, because they each exceed
the quantities in Table 1.
Shielded safe 2 has two Ir-192 sources, each having an
activity of 0.3 TBq (8.1 Ci). In this case, the sources would not
require increased controls while locked in the safe. The combined
activity does not exceed the threshold quantity 0.8 TBq (22 Ci).
Because certain barriers may cease to exist during source handling
operations (e.g., a storage location may be unlocked during periods of
active source usage), licensees should, to the extent practicable,
consider two modes of source usage--``operations'' (active source
usage) and ``shutdown'' (source storage mode). Whichever mode results
in the greatest inventory (considering barrier status) would require
increased controls for each location.
[FR Doc. E5-6718 Filed 11-30-05; 8:45 am]
BILLING CODE 7590-01-P